ABSTRAL

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

FENTANYL, AS CITRATE SALT

Disponibbli minn:

Kyowa Kirin Ltd

Kodiċi ATC:

N02AB03

INN (Isem Internazzjonali):

FENTANYL, AS CITRATE SALT

Dożaġġ:

600 Microgram

Għamla farmaċewtika:

Tablet Sublingual

Tip ta 'preskrizzjoni:

Product subject to prescription which may not be renewed (A)

Żona terapewtika:

fentanyl

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2009-05-22

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABSTRAL 100 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 200 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 300 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 400 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 600 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 800 MICROGRAM SUBLINGUAL TABLETS
Fentanyl
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Abstral is and what it is used for
2.
What you need to know before you take Abstral
3.
How to take Abstral
4.
Possible side effects
5.
How to store Abstral
6.
Contents of the pack and other information
1.
WHAT ABSTRAL IS AND WHAT IT IS USED FOR
Abstral_ _is a treatment for adults WHO MUST ALREADY REGULARLY BE
TAKING STRONG PAIN-RELIEVING
MEDICINE (OPIOIDS) for their persistent cancer pain, but require
treatment for their breakthrough pain.
If you are not sure, talk to your doctor.
Breakthrough pain is pain which occurs suddenly, even though you have
taken or used your usual
opioid pain-relieving medicine.
The active substance in Abstral sublingual tablets is fentanyl.
Fentanyl belongs to a group of strong
pain-relieving medicines called opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABSTRAL
DO NOT TAKE ABSTRAL

if you are allergic to fentanyl or any of the other ingredients of
this medicine (listed in section 6)

if you have severe breathing problems

If you are not regularly using a prescribed opioid medicine (e.g
codeine, fentanyl,
hydromorphone, morphine, oxycodone, pethidine), every day on a regular
schedule, for at
least a wee

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abstral 600 microgram sublingual tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains:
600 micrograms fentanyl (as citrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sublingual tablet
600 microgram sublingual tablet is a white “D”-shaped tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management of breakthrough pain in adult patients using opioid therapy
for chronic cancer pain.
Breakthrough pain is
a transient exacerbation of otherwise controlled chronic background
pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Abstral should only be administered to patients who are considered
tolerant to their opioid therapy for persistent cancer
pain.
Patients can be considered opioid tolerant if they take at least 60 mg
of oral morphine daily, at least
25 micrograms of transdermal fentanyl per hour, at least 30 mg of
oxycodone daily, at least 8 mg of oral
hydromorphone daily or an equianalgesic dose of another opioid for a
week or longer.
Method of administration:
Abstral sublingual tablets should be administered directly under the
tongue at the deepest part.
Abstral sublingual
tablets should not be swallowed, but allowed to completely dissolve in
the sublingual cavity without chewing or
sucking.
Patients should be advised not to eat or drink anything until the
sublingual tablet is completely dissolved.
In patients who have a dry mouth water may be used to moisten the
buccal mucosa before taking Abstral.
Dose titration:
The object of dose titration is to identify an optimal maintenance
dose for ongoing treatment of breakthrough pain
episodes. This optimal dose should provide adequate analgesia with an
acceptable level of adverse reactions.
The optimal dose of Abstral will be determined by upward titration, on
an individual patient basis.
Several doses are
available for use during the dose titration phase. The initial dose of
Abstral used should be 100 micrograms, titrating
upwards as ne